PROJECT SUMMARY: Phase V Pharmaceuticals, Inc., develops new formulations of drugs needed by under-served, vulnerable patient populations. The special needs of people with disabilities, in this case, both impaired mobility due to spasticity and impaired feeding due to dysphagia, are often overlooked. This project will solve an important problem for people in this group by developing a liquid formulation of tizanidine, the most promising new anti-spastic medication, which is easier to swallow than tablets and can be administered through feeding tubes. The results of this project will also lay a foundation for further research into the use of tizanidine in children and for chronic pain. Phase I of this SBIR will complete prototype drug development to identify a commercially feasible formula for this small molecule drug. The investigational design, research methods and analyses follow FDA guidelines, and have been successfully used by other businesses to obtain FDA marketing approval and commercialize their products. Phase I will also establish the bioequivalence analysis protocol to be followed in Phase II, and perform an initial feeding tube compatibility study with lead prototype drug candidates. DESCRIPTION OF RELEVANCE: The generic status of most spasticity drugs has limited additional formulation research because large drug companies have little incentive to pursue the relatively small market. Commercialization of a liquid formulation of tizanidine, however, will improve both the quality and the cost of drug delivery to this under-served patient population. Quality is increased by reducing extemporaneous compounding and increasing knowledge about the interactions between tizanidine and enteral feeding tubes; and cost of care is lowered by saving caregivers thousands of hours of drug preparation time, valued at more than $20 million per year, and reducing complications. [unreadable] [unreadable] [unreadable]